Medical implant having an anchoring system and method of use thereof

ABSTRACT

An improved cage that has an anchoring system and method of use thereof. The anchoring system has movable/expandable jaw portions that can expand vertically (i.e., upward and downward relative to the respective superior and inferior surfaces of the cage) so that the cage can be more securely implanted in position. The superior and inferior expandable portions of the anchoring system move vertically by the rotation of one or more spindles that is incorporated in the jaw mechanism (and/or by the rotation of a lead screw that is incorporated in the cage). In some embodiments, the medical implant (such as a cage) is itself non-expandable (i.e., the height of the medical implant does not change). In other embodiments, the medical implant (such as a cage) can be expanded independently of the anchoring system.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority benefits to U.S. ProvisionalApplication Ser. Nos. 62/621,663, and. 62/621,671, each filed on Jan.25, 2018, and each entitled “Medical Implant Having An Anchoring SystemAnd Method Of Use Thereof,” which patent applications are commonlyassigned to the Assignee of the present invention and are herebyincorporated herein by reference in their entirety for all purposes.

FIELD OF INVENTION

A medical implant having an anchoring system for anchoring and retainingthe medical implant (such as a cage) in place and method of use thereof.

BACKGROUND OF INVENTION

The spine is the axis of the skeleton on which all of the body partshang. In humans, the normal spine has seven cervical segments, twelvethoracic segments, five lumbar segments, five sacral segments (whichfuse to form the sacrum) and three to five coccygeal segments (whichfuse to form the coccyx. The lumbar spine attaches to the pelvis, and inturn is supported by the hip and leg bones. The bony vertebral bodies ofthe spine are separated by intervertebral discs, which act as joints butallow known degrees of flexion, extension, lateral bending, and axialrotation and translation.

Typical vertebra has a thick anterior bone mass called the vertebralbody, with a neural (vertebral) arch that arises from the posteriorsurface of the vertebral body. The centers of adjacent vertebrae aresupported by intervertebral discs. The disc and/or vertebral bodies maybe displaced or damaged due to trauma, disease, degenerative defects, oraging over an extended period of time. One result of this displacementor damage to an intervertebral disc or vertebral body may be chronicback pain. In many cases, to alleviate back pain from degenerated orherniated discs, part or all of the disc is removed and may be replacedwith an implant that promotes fusion of the remaining bony anatomy.

The success or failure of spinal fusion may depend upon several factors.For instance, the spacer or implant or cage used to fill the space leftby the removed disc must be sufficiently strong to support the spineunder a wide range of loading conditions. The spacer should also beconfigured so that it is likely to remain in place once it has beenpositioned in the spine by the surgeon. Additionally the material usedfor the spacer should be biocompatible material and should have aconfiguration that promotes bony ingrowth.

Other types of medical implants, such as corpectomy cages, have alsobeen developed to help support the spine and maintain the normal spacingbetween opposing vertebrae. Typically, corpectomy cages arepre-manufactured at various heights requiring that a cavity betweenopposing vertebrae be prepared and distracted to a dimensioncorresponding to the most suitably sized corpectomy cage. The surgicalprocedure to prepare the implant site can be difficult and lengthy.Moreover, the procedure can increase risk of trauma to the tissuessurrounding of the implant site.

Distractible corpectomy cages may be used as both a fusion device and/ora means for maintaining intervertebral spacing. Sometimes these implantsinclude an actuation mechanism that allows the corpectomy cage to beexpanded in situ to a size that corresponds to the cavity created whenthe damaged tissue is removed. These medical implants are referred to as“expandable medical implants” or “expandable cages.” The activationmechanism typically includes devices such as gears, threaded rods, andthe like, in mechanical engagement so as to expand or contract thedevice to a necessary distance between the vertebrae. For medicalimplants that have cages that do not expand in situ, these are referredto as “non-expandable medical implants” or “non-expandable cages.”

Cervical cages are also used to stabilize the spine during the fusionprocess. An example of a cervical cage is the Alamo® CervicalIntervertebral Body Fusion device (Alliance Spine, San Antonio, Tex.),which is shown in FIG. 1. In FIG. 1, cage 100 is shown inserted inspinal column 101. Such cage 100 can be manufactured from PEEK Optima®LT1 (Invibio Biomaterial Solutions, West Conshohocken, Pa.) per ASTMF2026 and includes tantalum markers per ASTM F560 for radiographicvisualization.

Furthermore, the cage can have the following features and benefits:

Length and width footprint can vary, such as 12 mm×14 mm, 14 mm×17 mm,and 16 mm×20 mm.

Heights can often vary in 1 mm increments from 5 mm to 12 mm (althoughthese heights can be outside these ranges depending upon the patient).

The cage can have teeth on superior and inferior surfaces, which aredesigned to provide secure engagement and to prevent expulsion andmigration.

The cage can be made of a biocompatible radiolucent polymer, whichallows clear assessment of bony fusion. Alternatively, the cage can bemade with a titanium alloy or a combination of a biocompatibleradiolucent polymer and titanium alloy.

The cage can have a large graft area, which allows for optimal bonegraft placement.

A top view of an exemplar intervertebral/interbody cage (cage 200) isshown in FIG. 2. For orientation purposes terms like “anterior,”“posterior,” “sagittal,” “superior,” and “inferior” are describingfront, back, side, top, and bottom, respectively for the normalorientation of use of a medical implant, such as cage 200. As shown inFIG. 2, cage has anterior end 202, posterior end 201, lateral sides 203and 204, superior face (which is the top view shown for cage 200 in FIG.2), and inferior face (which is not shown in FIG. 2 as it is theunderside of cage 200 as illustrate in this FIG. 2).

The “lateral” sides are positioned in a direction that is parallel tothe plane of the sagittal view, i.e., the lateral sides are in aparasagittal plane. When lateral sides move outward (“lateral”) orinward (“medial”) relative to one another, these lateral sides arereferred to as moving in a “lateral direction” or “medial direction,”respectively, in the normal orientation of use of an anterior medicalimplant of the present invention.

The “vertical” direction is the direction in the plane of thesuperior/inferior views, i.e., when the superior and inferior faces moveupward/downward relative to one another, these superior and inferiorfaces are referred to as moving in a vertical direction. It should benoted that due to symmetry of many medical implants, the “superior” and“inferior” sides are interchangeable (in that the medical device can beflipped). Thus, the superior and inferior sides are relative to oneanother. The height of a medical implant is measured in the verticaldirection. Moreover, when the medical implant has an expandable height,the expanding is done in the vertical direction.

As shown in FIG. 2, the cage does not expand either vertically orlaterally, and therefore is a non-expandable cage.

U.S. Pat. No. 8,328,872 issued Dec. 11, 2012 to Duffield et al.(“Duffield”) discloses an intervertebral implant for implantation in atreated area of an intervertebral space between vertebral bodies of aspine, which includes a cage having screw holes extending from a sideportion to the inferior (bottom) and superior surfaces (top) of thecage, in which the cage portion contains screws holes for receivingscrews. There is also a screw back out prevention mechanism adapted onthe plate portion and prevents the back out of screws from the screwholes. Illustration of the Duffield cage is shown in FIGS. 3A-3C. FIG.3A is a perspective view of the cage 300. FIG. 3B is a sagittal view ofcage 300. FIG. 3C is a perspective view of cage 300 with fasteners(screws 301) inserted. Other than changes in the reference numbers,FIGS. 3A-3C correspond to FIGS. 1, 3, and 7, respectively of Duffield.The screw holes of cage 300 are situated for receiving bone screws 301that can be attached to the adjacent vertebral bodies at differentangles to secure the cage in its position.

As the medical implant (cage) is subject to movement when thesurgeon/practitioner is inserting and securing it, there is a need foran improved anchoring system that allows a surgeon to more consistentlyand conveniently hold secure and anchor the medical implant in place.

SUMMARY OF INVENTION

The present invention regards an improved cage that has an anchoringsystem. The anchoring system has movable/expandable jaw portions thatcan expand vertically (i.e., upward and downward relative to therespective superior and inferior surfaces of the cage) so that the cagecan be more securely implanted in position. The superior and inferiorexpandable portions of the anchoring system move vertically by therotation of one or more spindles that is incorporated in the jawmechanism. In some embodiments, the medical implant (such as a cage) isitself non-expandable (i.e., the height of the medical implant does notchange). In other embodiments, the medical implant (such as a cage) canbe expanded independently of the anchoring system.

In general, in one aspect, the invention features a medical implant. Themedical implant includes a medical implant body having a superiorsurface and an inferior surface. The superior surface and the inferiorsurface are on opposing sides of the medical implant body. The medicalimplant further includes an anchoring mechanism attached to the medicalimplant body. The anchoring mechanism includes a superior anchoringsection having an anterior portion of the superior anchoring section anda posterior portion of the superior anchoring section. The anchoringmechanism further includes an inferior anchoring section having ananterior portion of the inferior anchoring section and a posteriorportion of the inferior anchoring section. The posterior portion of thesuperior anchoring section is pivotably connected to the posteriorportion of the inferior anchoring section at a pivot joint. The superioranchoring portion and inferior anchoring portion are operable to pivotabout the pivot joint such that the anterior portion of the superioranchoring portion and the anterior portion of the inferior anchoringportion pivot away from one another. The anchoring mechanism furtherincludes at least one spindle or lead screw that is operable to movebetween a first position and at least one second position. When the atleast one spindle or lead screw is in the first position, the anchoringmechanism is in the closed position with the anterior portion of thesuperior anchoring section in close proximity to the anterior portion ofthe inferior anchoring section. When the at least one spindle or leadscrew is in the second position the anchoring mechanism has moved to afirst opened position. In the first opened position, the anteriorportion of the superior anchoring section and the anterior portion ofthe inferior anchoring portion are pivoted away from one another aboutthe pivot joint. The at last one spindle or lead screw is operable to bemaintained at the second position to lock the anchoring mechanism in theopened position.

In general, in another aspect, the invention features a method. Themethod includes positioning a medical implant between a first vertebraeand a second vertebrae of a spinal column. The first vertebrae and thesecond vertebrae are adjacent. The medical implant includes a medicalimplant body and an anchoring system. The anchoring system includes asuperior anchoring section having an anterior portion of the superioranchoring section and a posterior portion of the superior anchoringsection. The anchoring system further includes an inferior anchoringsection having an anterior portion of the inferior anchoring section anda posterior portion of the inferior anchoring section. The posteriorportion of the superior anchoring section is pivotably connected to theposterior portion of the inferior anchoring section at a pivot jointsuch that the anterior portion of the superior anchoring section and theanterior portion of the inferior anchoring section can move pivotablyaway from one another. The anchoring mechanism is in a closed positionin which the anterior portion of the superior anchoring section in closeproximity to the anterior portion of the inferior anchoring section. Atleast one spindle or lead screw that is operable to move the anchoringmechanism from the closed position to at least one opened position. Themethod further includes coupling a rotating tool to at least one of theat least one spindle or lead screw. The method further includes usingthe rotating tool to rotate the spindle or lead screw to move theanchoring mechanism from the closed position to one of the at least oneopened position. The rotation of the spindle or lead screw causes theanterior portion of the superior anchoring section to move in adirection toward the first vertebrae and causes the anterior portion ofthe inferior anchoring section to move in a direction toward the secondvertebrae such that the anterior portion of the superior anchoringsection and the anterior portion of the inferior anchoring sectionanchor the cage implant between the first vertebrae and the secondvertebrae. The method further includes removing the rotating tool fromthe spindle or lead screw.

Implementations of the invention can include one or more of thefollowing features:

The at least one spindle or lead screw can be at least one spindle.

The medical implant body can include at least one superior recesslocated at an anterior superior portion of the medical implant body andat least one inferior recess located at an anterior inferior portion ofthe medical implant body. The anchoring mechanism can further include acompressor operatively connected to the superior anchoring section andthe inferior anchoring section that provides a compressive force tocompress the anchoring mechanism in the closed position. Each of the atleast one spindle can have a separator. The spindle can be locatedbetween the anterior portion of the superior anchoring section and theanterior portion of the inferior anchoring section and at the anteriorportion of the medical implant. The spindle can be rotatable so that theseparator is operable to move between a first spindle position and asecond spindle position. When the separator is in the first spindleposition, the anchoring mechanism can be in the closed position. Whenthe separator is in the second spindle position, the anchoring mechanismcan be in the first opened position. When the separator is in the secondposition, the separator can be in contact with at least one of the atleast one superior recess and at least one of the at least one inferiorrecess, which are operable to maintain the separator in the secondseparator position which maintains the spindle in the second position.

The anchoring mechanism can be a single-opened-height controlledanchoring system.

The anchoring mechanism can be a multiple-opened-height controlledanchoring system.

The medical implant body can include at least one additional superiorrecess located at the anterior superior portion of the medical implantbody and at least one additional inferior recess located at the anteriorinferior portion of the medical implant body. The medical implant caninclude a locking ring operable to lock the spindle. The spindle can berotatable so that the separator is operable to move between the firstspindle position and a third spindle position. When the separator is inthe third spindle position, the anchoring mechanism can be in a secondopened position that is different than the first opened position. Whenthe separator is in the third spindle position, the separator can be incontact with at least one of the at least one additional superior recessand at least one of the at least one additional inferior recess. Thelocking ring can be operable to lock the spindle from rotating.

The anchoring mechanism can include at least two spindles.

The at least one spindle or lead screw can be at least one lead screw,and the anchoring mechanism can be a variable-opened-height controlledanchoring system

The at least one lead screw can be operable to move to at least a thirdposition. When the at least one lead screw is in the third position, theanchoring mechanism can be in a second opened position in which theanterior portion of the superior anchoring section and the anteriorportion of the inferior anchoring portion are pivoted away from oneanother about the pivot joint even farther than when the lead screw wasin the second position.

When the at least one lead screw is in the third position, the anchoringmechanism can be in a fully opened position.

The at least one lead screw can be operable to move to at least a fourthposition. When the at least one lead screw is in the fourth position,the anchoring mechanism can be in a third opened position. In the thirdopened position, the anchoring mechanism can be more opened than when inthe first opened position and less opened when in the second openedposition.

The medical implant can be a cage.

The cage can be a lumbar cage.

The lumbar cage can include at least two of the spindles or at least twoof the lead screws.

The lumbar cage can be a thoraco-lumbar cage.

The lumbar cage can have a length and a width selected from a groupconsisting of 22 mm×30 mm, 24 mm×32 mm, 28 mm×36 mm, and 32 mm×40 mm.

The cage can be a cervical cage.

The cervical cage can include exactly one spindle or exactly one leadscrew.

The cervical cage can have a length and a width selected from a groupconsisting of 12 mm×14 mm, 14 mm×17 mm, and 16 mm×20 mm.

The medical implant can have a height between 5 mm and 22 mm.

The medical implant can be a vertebral body replacement having a heightbetween 20 mm and 100 mm.

The medical implant can include a material selected from a groupconsisting of biocompatible radiolucent polymers, non-radiolucent metalalloys, carbon fibers, composites of carbon fibers and polymers, andcombinations thereof.

The anchoring mechanism can include a material selected from a groupconsisting of metal alloys, ceramics, polymers, and composites thereof.

The anchoring mechanism can include a metal alloy or a carbon composite.

The metal alloy can include a titanium metal alloy.

The medical implant body can be a non-expandable medical implant body.

The medical implant body can be an expandable medical implant body.

The anchoring mechanism can be operable to anchor the medical implantbefore expanding the expandable medical implant body.

The expandable medical implant body can expand in a vertical directionto expand the height of the medical implant body. The maximum expandedheight of the expandable medical implant body can be less than thedifference between the anterior portion of the superior anchoringsection and the anterior portion of the inferior anchoring section whenthe anchoring mechanism is in the first opened position.

The medical implant can further include a plurality of fastener windowfeatures through which a fastener can pass through for anchoring of themedical implant.

The plurality of fastener window features can be operable for receivinga fastener selected from a group consisting of (a) fixed angle screws,(b) variable angle screws, (c) self-drilling screws, (d) self-tappingscrews, and (e) combinations thereof.

The present invention further regards an improved cage that hasmovable/expandable anchoring portions that can expand vertically upwardand downward (relative to the respective superior and inferior surfacesof the cage) so that the cage can be more securely implanted (i.e.,anchored) in position. The superior and inferior expandable portions arereadily expandable (vertically upwards and downwards) by the rotation ofa lead screw that is incorporated in the cage. In some embodiments, themedical implant (such as a cage) is itself non-expandable (i.e., theheight of the medical implant body does not change). In otherembodiments, the medical implant body (such as a cage) can also beexpanded independently of the anchoring system.

In general, in one aspect, the invention features a medical implant. Themedical implant includes a medical implant body having a superiorsurface and an inferior surface. The superior surface and the inferiorsurface are on opposing sides of the medical implant body. The medicalimplant further includes an anchoring mechanism that includes a firstexpandable section, a second expandable section, and a lead screw. Theanchoring mechanism is operable to expand a portion of the firstexpandable section in a first direction such that the portion of thefirst expandable section is outside of the superior surface of themedical implant body. The first direction is vertically upward relativeto the superior surface. The anchoring mechanism is further operable toexpand a portion of the second expandable section in a second directionsuch that the portion of the second expandable section is outside theinferior surface of the medical implant body. The second direction isvertically downward relative to the inferior surface. The lead screw isrotatably connected to the medical implant body and operable to rotatebetween a first position and a second position. When the lead screw isin the first position, the anchoring mechanism is in a closed positionin which the portion of the first expandable section is within themedical implant body and the portion of the second expandable section iswithin the medical implant body. When the lead screw is in the secondposition, the anchoring mechanism is in a second position in which theportion of the first expandable section is outside the superior surfaceof the medical implant body and the portion of the second expandablesection is outside the inferior surface of the medical implant body. Thelead screw is further operable to be locked in place (and not rotate) tomaintain the portion of the first expandable section and the portion ofthe second expandable section in place.

In general, in another aspect, the invention features a method. Themethod includes positioning a medical implant between a first vertebraeand a second vertebrae of a spinal column. The first vertebrae and thesecond vertebrae are adjacent. The medical implant includes a medicalimplant body having a superior surface and an inferior surface. Thesuperior surface and the inferior surface are on opposing sides of themedical implant body. The medical implant further includes an anchoringmechanism that includes a first expandable section, a second expandablesection, and a lead screw. The anchoring mechanism is operable to expanda portion of the first expandable section in a first direction such thatthe portion of the first expandable section is outside of the superiorsurface of the medical implant body. The first direction is verticallyupward relative to the superior surface. The anchoring mechanism isfurther operable to expand a portion of the second expandable section ina second direction such that the portion of the second expandablesection is outside the inferior surface of the medical implant body. Thesecond direction is vertically downward relative to the inferiorsurface. The lead screw is rotatably connected to the medical implantbody and operable to rotate between a first position and a secondposition. When the lead screw is in the first position, the anchoringmechanism is in a closed position in which the portion of the firstexpandable section is within the medical implant body and the portion ofthe second expandable section is within the medical implant body. Whenthe lead screw is in the second position, the anchoring mechanism is ina second position in which the portion of the first expandable sectionis outside the superior surface of the medical implant body and theportion of the second expandable section is outside the inferior surfaceof the medical implant body. The lead screw is further operable to belocked in place (and not rotate) to maintain the portion of the firstexpandable section and the portion of the second expandable section inplace. The method further includes coupling a rotating tool to the leadscrew. The method further includes using the rotating tool to rotate thelead screw to move the anchoring mechanism from the closed position tothe opened position. The rotation of the lead screw causes the portionof the first expandable section to move in a direction toward the firstvertebrae and causes the portion of the second expandable section tomove in a direction toward the second vertebrae such that the anchoringmechanism anchors the medical implant between the first vertebrae andthe second vertebrae. The method further includes removing the rotatingtool from the lead screw.

The foregoing has outlined rather broadly the features and technicaladvantages of the invention in order that the detailed description ofthe invention that follows may be better understood. Additional featuresand advantages of the invention will be described hereinafter that formthe subject of the claims of the invention. It should be appreciated bythose skilled in the art that the conception and the specificembodiments disclosed may be readily utilized as a basis for modifyingor designing other structures for carrying out the same purposes of theinvention. It should also be realized by those skilled in the art thatsuch equivalent constructions do not depart from the spirit and scope ofthe invention as set forth in the appended claims.

It is also to be understood that the invention is not limited in itsapplication to the details of construction and to the arrangements ofthe components set forth in the following description or illustrated inthe drawings. The invention is capable of other embodiments and of beingpracticed and carried out in various ways. Also, it is to be understoodthat the phraseology and terminology employed herein are for the purposeof the description and should not be regarded as limiting.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present invention, and theadvantages thereof, reference is now made to the following descriptionstaken in conjunction with the accompanying drawings, in which:

FIG. 1 depicts a prior art cage inserted in a spinal column.

FIG. 2 depicts a prior art, non-expandable cage.

FIGS. 3A-3C depict different views of a prior art, non-expandable cage.FIG. 3A shows a perspective view. FIG. 3B shows a sagittal view. FIG. 3Cshows a perspective view with fasteners.

FIG. 4A-4C depict different views of a lumbar cage embodiment of thepresent invention in which the anchoring system is asingle-opened-height controlled anchoring system shown in the closed (orunanchored) position.

FIG. 5A-5C depict different views of the lumbar cage embodiment of thepresent invention shown in FIGS. 4A-4C in which the single-opened-heightcontrolled anchoring system is shown in the opened (or anchored)position.

FIG. 6A-6D depict a cervical embodiment of the present invention havinga single-opened-height controlled anchoring system that is in the closed(or unanchored) position, which embodiment has similarities in itsdesign to that of the lumbar cage embodiment shown in FIGS. 4A-4C and5A-5C.

FIG. 7A-7D depict different views of the cervical cage embodiment of thepresent invention shown in FIGS. 6A-6D in which the single-opened-heightcontrolled anchoring system is shown in the opened (or anchored)position.

FIGS. 8A-8D depict different views of an alternative cervical cageembodiment of the present invention in which the anchoring system is avariable-opened-height controlled anchoring system shown in the closed(or unanchored) position.

FIGS. 9A-9D depict different views of the alternative cervical cageembodiment of the present invention shown in FIGS. 8A-8D in which thevariable-opened-height controlled anchoring system is shown in an opened(or anchored) position (in which the variable-opened-height controlledanchoring system is only partially opened).

FIGS. 10A-10D depict different views of the alternative cervical cageembodiment of the present invention shown in FIGS. 8A-8D in which thevariable-opened-height controlled anchoring system is shown in an opened(or anchored) position (in which the anchoring system is more partiallyopened as compared to the views shown in FIGS. 9A-9D).

FIGS. 11A-11D depict different views of the alternative lumbar cageembodiment of the present invention shown in FIGS. 11A-11D in which thevariable-opened-height controlled anchoring system is shown in an opened(or anchored) position (in which the anchoring system is completelyopened and further opened as compared to the views shown in FIGS. 9A-9Dand FIGS. 10A-10D).

FIG. 12A-12E depict a lumbar embodiment of the present invention havinga single-opened-height controlled anchoring system that is in the closed(or unanchored) position, which embodiment has similarities in itsdesign to that of the lumbar cage embodiment shown in FIGS. 4A-4C and5A-5C.

FIG. 13A-13FD depict different views of the lumbar cage embodiment ofthe present invention shown in FIGS. 12A-12E in which thesingle-opened-height controlled anchoring system is shown in the opened(or anchored) position.

FIGS. 14A-14C depict different views of another embodiment of thepresent invention.

FIGS. 15A-15C depict different views of another embodiment of thepresent invention.

FIGS. 16A-16C depict different views of another embodiment of thepresent invention.

FIGS. 17A-17D depict different views of another embodiment of thepresent invention.

FIGS. 18A-18H depict different views of another embodiment of thepresent invention.

FIG. 19 is a flowchart of a surgical technique using the medicalimplants of the present invention.

DETAILED DESCRIPTION

The medical implant having an anchoring system for anchoring andretaining the medical implant (such as a cage) in place and method ofuse thereof. The medical implant can be placed between the vertebrae andthen utilizing a tool to rotate the anchoring system from the closedposition to the opened (or partially opened) position, to secure andanchor the medical implant in place. In some embodiments, the partiallyopened positions is controllable (i.e., the degree by which theanchoring system is opened is variable and/or can be controlled invariable states. This anchoring can be done without having to insert anyscrews or other fasteners. Optionally, after the anchoring system is inplace, more traditional fasteners (such as screws) can then be utilizedfor further securing of the medical implant. Such optional anchoring isdone more likely in lumbar cage embodiments (as compared to cervicalcage embodiments).

The medical implant fixation instrument can also afford the surgeon withgraft windows so that the bone growth inducing substance can stillutilized with the medical implant or so that fusion can be more readilyviewed by the surgeon/practitioner.

While the figures refer to medical implant fixation system to be usedfor an anterior placement orientation, the medical implant fixationsystem can be used in orientation and with a variety of medical implantsystems (such as with plates).

Cage Embodiments with Single-Opened-Height Controlled Anchoring Systems

Referring to the figures, a first embodiment of the present invention isdepicted in FIGS. 4A-4C and FIGS. 5A-5C, which is a cage embodiment thathas a single-opened position. “Single-opened position” refers to thatthe cage embodiment has only one vertical height of the anchoring systemwhen in the opened position, i.e., the vertical height cannot be variedby the surgeon/practitioner once the particular cage has been selected(except of course, for the change in vertical height caused by movingthe anchoring system between the closed and open positions). Such cageembodiments are referred to herein as cage embodiments having“single-opened-height controlled anchoring systems.” Hence, thesurgeon/practitioner must determine the expected vertical opened-heightof the anchoring system when selecting which cage embodiment to use. Asdiscussed below, some cage embodiments have variable opened-heights inthat the anchoring system can be partially opened to various degrees,including completely opened. Such cage embodiments are referred toherein as cage embodiments having “variable-opened-height controlledanchoring systems.” Such variable-opened-height controlled anchoringsystems provide the surgeon/practitioner the ability to vary thevertical height when anchoring those cage embodiments.

FIGS. 4A-4C show cage 400 with the anchoring portions (superioranchoring portion 402 and inferior anchoring portion 403) in a closedposition. FIGS. 4A-4C are, respectively, perspective, anterior, andsuperior view of cage 400.

As shown in FIGS. 4A-4C, the cage 400 has a cage body 401 which is ofstandard materials and size of typical intervertebral/interbody cage.The cage 401 can be made of a polymer, such as PEEK Optima® LT1 or atitanium alloy (such as per ASTM F136). Connected to the cage body 401is an anchoring mechanism (such as a jaw mechanism) that includes (a) asuperior anchoring section 402 (superior jaw section) and an inferioranchoring section 403 (inferior jaw section). The anchoring sections canbe made of a polymer, a metal (such as a titanium alloy), or acombination thereof.

In the closed position (such as shown in FIGS. 4A-4C), the superioranchoring section 402 and inferior anchoring section 403 are in closeproximity, typically in contact, with one another. The superioranchoring section 402 and inferior anchoring section 403 are pivotablyconnected to one another at pivot joint 404. The pivot joint 404 islocated toward the posterior section of the cage 400 such that when thesuperior anchoring section 402 and inferior anchoring section 403 pivotabout pivot joint 404, they will separate farther apart at the anteriorsection of cage 400. On the other side of the pivot joint 404 (closer tothe posterior section of cage 400), the superior anchoring section 402and inferior anchoring section 403 have end portions 405. Generally, thesuperior anchoring section 402 and inferior anchoring section 403 arespring loaded (such as by end portions 405) or have some othercompression mechanism so that the forces are compressing superioranchoring section 402 and inferior anchoring section 403 toward oneanother. I.e., absent other forces, the superior anchoring section 402and inferior anchoring section 403 will tend toward contacting oneanother, such that the anchoring system in cage 400 will be in theclosed position, as depicted in FIGS. 4A-4C.

Cage 400 further includes a spindle 406 that is rotatable. Spindle 406also has a central feature 408 that is operable to accept a rotationaltool, so that spindle 406 can be rotated. As shown in FIGS. 4A-4C,spindle 406 is located at the anterior of cage 400 and is locatedbetween the anterior portions of superior anchoring section 402 andinferior anchoring section 403. Spindle 406 includes a separator 407that is in contact with the superior anchoring section 402 and inferioranchoring section 403.

Again, FIGS. 4A-4C show the anchoring mechanism in the closed position,accordingly, the separator 407 of the spindle 406 is positioned in adirection that provides for the superior anchoring section 402 andinferior anchoring section 403 to be in close proximity (typically incontact) with one another.

FIGS. 5A-5C show cage 400 in an opened position. In this openedposition, spindle 406 has been rotated (generally by around 90 degrees)so that each of the separators 407 are now pushing superior anchoringsection 402 and inferior anchoring section 403 outward (i.e., superioranchoring section 402 is being pushed vertically in a superior directionand inferior anchoring section 403 is being pushed vertically in aninferior direction). This movement of superior anchoring section 402 andinferior anchoring section 403 will expand the anchoring system in avertical direction to anchor cage 400 in place. While this moves theanterior portions of the anchoring sections 402-403 in oppositedirections vertically, the height of the cage body 401 does not itselfexpand. Thus, the anchoring sections 402-403 anchor and secure the cagebody 401.

Superior anchoring section 402 and inferior anchoring section 403 haverecesses 409 located on the sides contacting the separator 407 so thatwhen positioned to open the jaw mechanism, separator 407 fits intorecesses 409. The frictional forces will maintain the separator 407 insuch position, which will thus maintain the jaw mechanism open (and thecage body 401 anchored).

As shown in FIGS. 4A-4C and FIGS. 5A-5C, the cage 400 has two spindles407. This generally is because of the size of a lumbar cage. However,the lumbar cage can be utilized with only one spindle to move andmaintain the jaw mechanism in an open position. Moreover the cage can bea cervical cage, which generally has one spindle (although, it too canhave two spindles, if so desired).

A second embodiment having a single-opened-height controlled anchoringsystem is illustrated in FIGS. 6A-6D and FIGS. 7A-7D. This embodiment issimilar to that of cage 400, except that the cage 600 is a cervical cageembodiment having only one spindle in the single-opened-heightcontrolled anchoring system. Again, cervical cage embodiments generallywill have one spindle, which lumbar cage embodiments will have twospindles. The views of FIGS. 6A-6D and FIGS. 7A-7D are as follows (a)each of FIGS. 6A and 7A are perspective views of cage 600, (b) each ofFIGS. 6B and 7B are anterior views of cage 600, (c) each of FIGS. 6C and7C are superior/inferior views of cage 600, and (d) each of FIGS. 6D and7D are sagittal views of cage 1100 (with the anterior portion of cage600 depicted toward the left in FIGS. 6D and 7D). (The superior/inferiorviews are interchangeable in this embodiment, because the device issymmetric and the superior/inferior view is dependent upon theorientation of the cage 600.

FIGS. 6A-6D show the cage 600 in the closed (i.e., unanchored) form.Cage 600 has a cage body 601 and a jaw mechanism. The jaw mechanism hassuperior jaw section 602 and inferior jaw section 603 that are pivotablyconnected to one another at pivot joint 604. On the other side of thepivot joint 604, the superior jaw section 602 and inferior jaw section603 have end portions 605. Similar to cage 400 shown in FIG. 4A-4C andFIGS. 5A-5C, these are spring loaded so that the forces are compressingsuperior jaw section 602 and inferior jaw section 603 toward oneanother. Cage 600 further has a spindle 606 having a separator 607 and acentral feature 608 that is operable to accept a rotational tool, sothat spindle 606 can be rotated.

FIGS. 7A-7D show the cage 600 in the opened (i.e., anchored) form.Superior jaw section 602 and inferior jaw section 603 have recesses 701(located in the anterior portions of superior jaw section 602 andinferior jaw section 603) in which separator 607 fits when the jawmechanism is positioned in the open position. Again, the frictionalforces will maintain the separator 607 in such position, which will thusmaintain the jaw mechanism open (and the cage 600 anchored). Optionally,a slot ring (such as shown in FIGS. 12A-12E, and FIGS. 13A-13F,discussed below) can be utilized to maintain the jaw mechanism open.

While not shown in FIGS. 4A-4C, FIGS. 5A-5C, FIGS. 6A-6D, and FIGS.7A-7D the cage embodiments can include holes through which otherfasteners (such as screws) can then be inserted for further securing ofthe device. Such holes and fasteners are illustrated in FIGS. 3A-3C.Since the cages 400 and 600 can be anchored and secured prior to theinsertion of these additional fasteners (using the anchoring systems),this provides additional freedom for the surgeon or other practitionerto properly insert and secure these fasteners because the cage isalready being anchored.

Cage Embodiments with Variable-Opened-Height Controlled AnchoringSystems

Referring to the figures, another embodiment of the present invention inFIGS. 8A-8D, 9A-9D, 10A-10D, and 11A-11D, which is a cervical cageembodiment having a variable-opened-height controlled anchoring system.FIGS. 8A-8D depict different views of cage 800 embodiment of the presentinvention in which the variable-opened-height controlled anchoringsystem is in the closed (or unanchored) position. The perspectives ofFIGS. 8A-8D are, respectively, FIG. 8A is a perspective view, FIG. 8B isan anterior view, FIG. 8C is a superior/inferior view, and FIG. 8D is asagittal view (with the anterior portion of cage 800 depicted toward theleft in the figure).

The corresponding views are depicted in FIGS. 9A-9D, FIGS. 10A-10D, andFIGS. 11A-11D. I.e., (a) each of FIGS. 9A, 10A, and 11A are perspectiveviews of cage 800, (b) each of FIGS. 9B, 10B, and 11B are anterior viewsof cage 800, (c) each of FIGS. 9C, 10C, and 11C are superior views ofcage 800, and (d) each of FIGS. 9D, 10D, and 11D are sagittal views ofcage 800. Unlike FIGS. 8A-8D, each of FIGS. 9A-9D, FIGS. 10A-10D, andFIGS. 11A-11D show cage 800 in various degrees of heights of theanchoring system in the opened position (with the height progressivelygreater for cage 800 as each of FIGS. 9A-9D, FIGS. 10A-10D, and FIGS.11A-11D). By way of example, FIGS. 9A-9D can be depicting a height of 9mm, FIGS. 10A-10D can be depicting a height of 10 mm, and FIGS. 11A-11Dcan be depicting a height of 11 mm. Such height of the anchoring systemis measured from the anterior portions of the superior anchoring section802 and inferior anchoring system 803.

Referring to FIG. 8A, this reflects similarities in cage 800 componentswith that of cage 400. Similar to cage 400, cage 800 has cage body 801,superior anchoring section 802, inferior anchoring section 803, andpivot joint 804. However, the driving mechanism for the changing theheight of the variable-controlled anchoring system is performed with oneor more lead screws. Cage 800 is shown with two lead screws 807 a and807 b. Lead screws 807 a and 807 b also each have a central feature 808a and 808 b, respectively, that are operable to accept a rotationaltool, so that each of lead screws 807 a and 807 b can be rotated. Leadscrews 807 a and 807 b can be rotated independently from one another.

Superior anchoring section 802 includes recesses 809 and inferioranchoring section 803 includes recesses 810 that come in contact with alead screw (such as lead screw 808 b) such that when lead screw 807 b isrotated, the superior anchoring section 802 and inferior anchoringsection 803 will pivot at pivot joint 804, allowing the anterior portionof superior anchoring section 802 to move vertically with respect to theanterior portion of inferior anchoring section. By such rotation of thelead screws 808 a and 808 b, the anchoring system can be varied inheight.

This change in height of cage 800 is depicted progressively in FIGS.9A-9D, FIGS. 10A-10D, and FIGS. 11A-11D. In FIGS. 9A-9D, cage 800 isshown in a partially opened position in which, lead screws 807 a and 807b have been rotated so that they are partially inserted into cage 800.This has caused the portion of superior anchoring section 802 andinferior anchoring section 803 to pivot at pivot joint 804, which hasresulted in the anterior portion of superior anchoring section 802 tomove vertically with respect to the anterior portion of inferioranchoring section 803. This resulting height is more clearly seen in theanterior view of FIG. 9B and the sagittal view of FIG. 9D. Again, forexample, in cage 800 in FIGS. 9A-9D, this height can be 9 mm.

FIGS. 10A-10D depict that lead screws 807 a and 807 b have been furtherrotated so that they are further partially inserted into cage 800. Thishas resulting in in the anterior portion of superior anchoring section802 to move even further vertically with respect to the anterior portionof inferior anchoring section 803. This resulting height is more clearlyseen in the anterior view of FIG. 10B and the sagittal view of FIG. 10D.Again, for example, in cage 800 in FIGS. 10A-10D, this height can be 10mm.

FIGS. 11A-11D depict that lead screws 807 a and 807 b have been furtherrotated so that they are completely inserted into cage 800. This hasresulting in in the anterior portion of superior anchoring section 802to move even further vertically with respect to the anterior portion ofinferior anchoring section 803. This resulting height is more clearlyseen in the anterior view of FIG. 11B and the sagittal view of FIG. 11D.Again, for example, in cage 800 in FIGS. 11A-11D, this height can be 11mm.

By the rotation of lead screws 807 a and 807 b, the height of theanchoring system can be controllably varied.

Alternatively, a variable-opened-height controlled anchoring system withone lead screw can be utilized.

A second embodiment having a variable-opened-height controlled anchoringsystem is illustrated in FIGS. 12A-12E and FIGS. 13A-13F. Thisembodiment of FIGS. 12A-12E and FIGS. 13A-13F (cage 1200) hassimilarities with respect to the single-opened-height controlledanchoring systems shown in FIGS. 4A-4C, FIGS. 5A-5C, FIGS. 6A-6D, andFIGS. 7A-7D, except that for the variable-opened-height controlledanchoring system of cage 1200 the spindle 1206 (or multiple spindles asthe case may be) having separators 1207 that can be positioned inpartially opened positions based upon the recesses (such as recesses1301 and recesses 1302). Once moved to the appropriate setting (for thedesired vertical size to be opened), the slot ring 1209 can then bepositioned to prevent the spindle 1206 from further movement.

The views of FIGS. 12A-12E and FIGS. 13A-13F are as follows (a) each ofFIGS. 12A and 13A are perspective views of cage 1200, (b) each of FIGS.12B and 13B are anterior views of cage 1200, (c) each of FIGS. 12C and13C are superior/inferior views of cage 1200, (d) each of FIGS. 12D and13D are sagittal views of cage 1200 (with the anterior portion of cage1200 depicted toward the left in FIGS. 12D and 13D), (e) each of FIGS.12E and 13E are posterior views of cage 1200, and (f) FIG. 13F is aperspective view of a cross section of cage 1200.

FIGS. 12A-12E show the cage 1200 in the closed (i.e., unanchored) form.Cage 1200 has a cage body 1201 and a jaw mechanism. The jaw mechanismhas superior jaw section 1202 and inferior jaw section 1203 that arepivotably connected to one another at pivot joint 1204. On the otherside of the pivot joint 1204, the superior jaw section 1202 and inferiorjaw section 1203 have end portions 1205. Similar to cages 400 and 600shown in (a) FIGS. 4A-4C and FIGS. 5A-5C and (b) FIGS. 6A-6D, and FIGS.7A-7D, respectively, these are spring loaded (with spring 1210) so thatthe forces are compressing superior jaw section 1202 and inferior jawsection 1203 toward one another. Cage 1200 further has a spindle 1206having a separator 1207 and a central feature 1208 that is operable toaccept a rotational tool, so that spindle 1206 can be rotated. Cage 1200also includes a slot ring 1209 that can be used to lock the spindle 1206in place to maintain the jaw mechanism in the desired position.

FIGS. 13A-13F show the cage 1200 in one of the opened (i.e., anchored)forms (and, as shown, the fully-opened position). Superior jaw section1202 and inferior jaw section 1203 have recesses 1301 (located in theanterior portions of superior jaw section 1202 and inferior jaw section1203) in which separator 1207 fits when the jaw mechanism is positionedin the full open position. Again, the frictional forces will maintainthe separator 1207 in such position, which will thus maintain the jawmechanism open (and the cage 1200 anchored). In this embodiment, theslot ring 1209 can be utilized to maintain the jaw mechanism open. Theslot ring 1209 in the locked position is shown in FIG. 13F (as shown incross-section cut along the plane of slot ring 1209, which are lockedusing spindle serrations 1303 that engage with catch teeth of the slotring 1209).

Unlike cage 600, cage 1200 is a variable-opened-height controlledanchoring system in that the separator 1207 can be positioned withinother recesses, such as recesses 1302. When, separator 1207 ispositioned in recesses 1302, the separation of the anterior portions ofthe superior jaw section 1202 and inferior jaw section 1203 is not asgreat as when the separator 1207 is positioned in recesses 1301. Thus,this provides the surgeon or other practitioner with some varyingheights at which to set the variable-opened-height controlled anchoringsystem in cage 1200. For example, when the separator 1207 is in recesses1302, the height of the anterior portions of the superior jaw section1202 and inferior jaw section 1203 can be 12 mm, and when the separator1207 is in recesses 1301, the height of the anterior portions of thesuperior jaw section 1202 and inferior jaw section 1203 can be 16 mm.

While not shown in FIGS. 8A-8D, FIGS. 9A-9D, FIGS. 10A-10B, FIGS.11A-11D, FIGS. 12A-12E, and FIGS. 13A-13F the cage embodiments caninclude holes through which other fasteners (such as screws) can then beinserted for further securing of the device. Such holes and fastenersare illustrated in FIGS. 3A-3C. Since cages 800 and 1200 can be anchoredand secured prior to the insertion of these additional fasteners (usingthe anchoring systems), this provides additional freedom for the surgeonor other practitioner to properly insert and secure these fastenersbecause the cage is already being anchored.

Additional Cage Embodiments

Another embodiment of the present invention (cage 1400) is depicted inFIGS. 14A-14C. FIG. 14A is a superior/inferior view of cage 1400 in thecollapsed (non-expanded) form. FIG. 14B is a sagittal view of cage 1400in a collapsed form (with the anterior portion of cage 1400 to the leftin FIG. 14B). FIG. 14C is a sagittal view of cage 1400 in an expandedform (with the anterior portion of cage 1400 to the left in FIG. 14C).For better understanding, the cage portion (or spacer portion) 1404 ofcage 1400 is shown transparently.

Cage 1400 has a cage portion 1404 that includes a top expandable portion1401 and a bottom expandable portion 1402 that can be moved verticallymoved, respectively, up and down relative to the superior/inferiorsurfaces of cage 1400 using lead screw 1403. Lead screw 1403 has an endthat can be engaged with a positioning tool that can be used to hold onto the cage 1400 to properly position the cage 1400 between the opposingvertebrae.

When positioning the cage 1400, the positioning tool is capable ofrotating the lead screw 1403 (either permanently or is locked in placeto avoid rotation). Once the cage 1400 is in place, either thepositioning tool is unlocked (and thus capable of rotating) or isunattached and a second tool (a rotational tool) is then attached to thelead screw. The lead screw is then rotated in a first direction (eitherclockwise or counterclockwise) which moves the lead screw 1403 forward(i.e., toward the front of the cage), which, in turn, causes the collarcomponent 1405 to move the top expandable portion 1401 to move upwardrelative to cage portion 1404 and bottom expandable portion 1402 to movedownward relative to cage portion 1404. Once the top expandable portion1401 and the bottom expandable portion 1402 are expanded to the desireddepths (upwards and downward), the cage is then anchored in place. Thetool can then be unattached to the cage 1400 and, optionally, a lockingmechanism can be utilized to maintain the lead screw in place (so thatit cannot rotate), which will maintain the expandable portions 1401-1402in the expanded position.

If desired, such as for removal of the cage or for repositioning of thecage, the rotational tool can be reattached and the lead screw can berotated in a second direction, which will indirectly collapse expandableportions 1401-1402.

In this design, void spaces 1406 are within the cage 1400 that are notaffected by the expansion of the expandable portions 1401-1402. It is inthese void spaces 1406 that bone growth inducing substance can beplaced.

Another embodiment of the present invention is shown in FIGS. 15A-15C.FIG. 15A is a superior/inferior view of cage 1500 in the collapsed(non-expanded) form. FIG. 15B is a sagittal view of cage 1500 in acollapsed form (with the anterior portion of cage 1500 to the left inFIG. 15B), and (c) in FIG. 15C is a perspective view of cage 1500 in acollapsed form. For better understanding, the cage portion (or spacerportion) 1504 of cage 1500 is shown transparently.

As shown in FIGS. 15A-15C, the cage 1500 has an expandable flexiblespring portion 1501 having an elliptical hole 1502. The expandableportion 1501 is capable of expanding vertically upwards and downwardsrelative to cage portion 1504. As the lead screw 1503 is rotated (by therotational tool), this will move the lead screw 1503 to move forward(i.e., toward the front of the cage), which, in turn, causes theexpandable portion 1501 to bow outward both upward and downward relativeto cage portion 1504. Hence, this too anchors cage 1500 in a fashionsimilar to cage 1400 and can be utilized in a similar manner asdescribed above. The cage 1500 likewise has a void spaces (void spaces1506) in which bone growth inducing substance can be placed.

Another embodiment of the present invention is shown in FIGS. 16A-16C.FIG. 16A a superior/inferior view of cage 1600 in the collapsed(non-expanded) form. FIG. 16B is a sagittal view of cage 1600 in acollapsed form (with the anterior portion of cage 1600 to the left inFIG. 16B). FIG. 16C is a sagittal view of cage 1600 in an expanded form(with the anterior portion of cage 1600 to the left in FIG. 16C). Forbetter understanding, the cage portion (or spacer portion) 1604 of cage1600 is shown transparently.

As shown in FIGS. 16A-16C, the cage 1600 has a superior expandablelinkage portion 1601 and an inferior expandable linkage portion 1602that scissor/pivot vertically up and down, respectively (relative tocage portion 1604) as lead screw 1603 is rotated and moves forwardrelative to cage portion 1604. When these are expanded to the desireddepths (vertically upwards and downward), the cage is then anchored inplace. The expandable portion 1601 is capable of expanding verticallyupwards and downwards relative to cage portion 1604. As the lead screw1603 is rotated (by the rotational tool), this will move the lead screw1603 to move forward (i.e., toward the front of the cage), which, inturn, causes the expandable portions 1601 and 1602 to pivot outward bothupward and downward relative to cage portion 1604. Hence, these tooanchor cage 1600 in a fashion similar to cages 1400 and 1500 and can beutilized in a similar manner as described above.

Cage 1600 likewise has a void spaces (void spaces 1606) in which bonegrowth inducing substance can be placed.

Another embodiment of the present invention is shown in FIGS. 17A-17D.FIG. 17A a superior/inferior view of cage 1700 in the collapsed(non-expanded) form. FIG. 17B, a sagittal view of cage 1700 in acollapsed form (with the anterior portion of cage 1700 to the left inFIG. 17B). FIG. 17C is a sagittal view of cage 1700 in a partiallyexpanded form (with the anterior portion of cage 1700 to the left inFIG. 17C). FIG. 17D is a sagittal view of cage 1700 in a fully expandedform (with the anterior portion of cage 1700 to the left in FIG. 17D).For better understanding, the cage portion (or spacer portion) 1704 ofcage 1700 is shown transparently.

As shown in FIGS. 17A-17D, the cage 1700 has a top expandable stabilizerportion 1701 and a bottom expandable stabilizer portion 1702 that canmove vertically upward and downward relative to cage portion 1704 andthus can be utilized similar to cages 1400-1600 shown above. Lead screw1703 has two portions, which generally will have different diameters.The first lead screw portion (portion 1707) is rotated and due tothreading in cage portion 1704 will move forward relative to cageportion 1704. The second lead screw portion (portion 1708) engages withgear teeth 1710 on axle feature 1709. As portion 1708 moves forwardrelative to cage portion 1704, this will cause the gear teeth 1710 tomesh angularly about axle 1709, which will rotate top expandablestabilizer portion 1701 and a bottom expandable stabilizer portion 1702upward and downward symmetrically, as shown in FIGS. 17C-17D. Hence,these too anchor cage 1700 in a fashion similar to cages 1400-1600 andcan be utilized in a similar manner as described above.

Cage 1700 likewise has a void spaces (void spaces 1706) in which bonegrowth inducing substance can be placed.

Another embodiment of the present invention is shown in FIGS. 18A-1811.FIG. 18A a superior/inferior view of cage 1800 in the collapsed(non-expanded) form. FIG. 18B is a sagittal view of cage 1800 in acollapsed form (with the anterior portion of cage 1800 to the left inFIG. 18B). FIG. 18C is a sagittal view of cage 1800 in a partiallyexpanded form (with the anterior portion of cage 1800 to the left inFIG. 18C). FIG. 18D is a sagittal view of cage 1800 in a more partiallyexpanded form (with the anterior portion of cage 1800 to the left inFIG. 18D). FIG. 18E is a sagittal view of cage 1800 in an even morepartially expanded form (with the anterior portion of cage 1800 to theleft in FIG. 18E). FIG. 18F is a sagittal view of cage 1800 in a fullyexpanded form (with the anterior portion of cage 1800 to the left inFIG. 18F). FIG. 18G is a perspective view of cage 1800 in a fullyexpanded form. FIG. 1811 is a superior/inferior view of cage 1800 in theeven more partially expanded form (as shown in FIG. 18E). For betterunderstanding, the cage portion (or spacer portion) 1804 of cage 1800 isshown transparently.

As shown in FIGS. 18A-1811, the cage 1800 has a top expandablestabilizer portions 1801 a and 1801 b and bottom expandable stabilizerportions 1802 a and 1802 b. Superior expandable stabilizer portions 1801a and 1801 b can move vertically upward and laterally left and right,respectively, relative to cage portion 1804, while inferior expandablestabilizer portions 1802 a and 1802 b can move vertically downward andlaterally left and right, respectively, relative to cage portion 1804.Such movement of superior expandable stabilizer portions 1801 a and 1801b and inferior expandable stabilizer portions 1802 a and 1802 b occursas lead screw 1803 is rotated and moved forward relative to cage portion1804. When these are expanded to the desired depths (left upwards, rightupwards, left downwards, and right downwards), the cage 1800 is thenanchored in place. Hence, these too anchor cage 1800 in a fashionsimilar to cages 1400-1700 and can be utilized in a similar manner asdescribed above.

Cage 1800 likewise has a void spaces (void spaces 1806) in which bonegrowth inducing substance can be placed

Further Cage Embodiments with Anchoring Systems

Further, cage 400 (shown in FIGS. 4A-4C and FIGS. 5A-5C), cage 600(shown in FIGS. 6A-6D and FIGS. 7A-7D), cage 800 (shown in FIGS. 8A-8D,FIGS. 9A-9D, FIGS. 10A-10B, and FIGS. 11A-11D), cage 1200 (shown inFIGS. 12A-12E and FIGS. 13A-13F), cage 1400 (shown in FIGS. 14A-14C),cage 1500 (shown in FIGS. 15A-15C), cage 1600 (shown in FIGS. 6A-16C),cage 1700 (shown in FIGS. 17A-17D) and cage 1800 (shown in FIGS.18A-18H) are depicted as non-expandable cages. In further alternativeembodiments, the cage itself can be an expandable cage (vertically,laterally, or both). In the case that that the cage is expandable, theanchoring system needs to be such that it is independently moved fromthe closed position to an open positioned. Moreover, the anteriorportions of superior anchoring section and inferior anchoring sectiongenerally must be at a greater difference than the height of theexpandable cage (after expanded). In such way, the anchoring mechanismwill be anchored even after the implant itself is expanded.

Uses of Cage Embodiments with Anchoring Systems

A surgeon or other practitioner can use this medical implant in a methodthat includes the following steps:

FIG. 19 is a flowchart of a surgical technique using the medical implantthat includes a cage having an anchoring system of the present invention(such as cages 400, 600, 800, 1200, 1400, 1500, 1600, 1700, and 1800).

In step 1901, the surgeon/practitioner performs preoperative planning.This includes determination of the appropriate height of the cage beforethe surgery. To achieve maximum segment height restoration, the cageshould be selected having the largest possible height that can be safelyinserted without disturbing the surrounding neural elements. Typically,the height is between 5 and 20 mm. Such preoperative planning shouldalso take into account what the anchoring height should be. For example,if a single-opened-height controlled anchoring system is to be utilized,the surgeon/practitioner should select a cage that also includes theheight the surgeon/practitioner desires. Further for example, if avariable-opened-height controlled anchoring system, thesurgeon/practitioner should select a cage having a range of height thatincludes the height the surgeon/practitioner desires. (This preoperativeplanned heights of the cage and the anchoring system can be adjusted instep 1904 described below)

In step 1902, the surgeon/practitioner creates disc access. This, ofcourse, depends on the surgical procedure being utilized by thesurgeon/practitioner. I.e., the procedure an approach from the anterior,posterior, etc.). For the purposes of the description herein, theprocedure will be oriented for an anterior approach. A person of skillin the art would understand how such procedure described below would bealtered for other approaches. For instance in a typical anteriorapproach, the patient is placed in the prone position. From the midlineanteriorly, the surgeon/practitioner would dissect the skin,subcutaneous tissues, and to expose (anteriorly) a portion of the spinalcolumn. This exposed a disc space between adjacent vertebrae (or discs).

In step 1903, the surgeon/practitioner prepares the disc space. Usingthe appropriate instruments, the surgeon/practitioner removes the discmaterial. The surgeon/practitioner can decorticate the cartilaginousendplates from the surface of adjacent vertebral endplates untilbleeding bone is obtained.

In step 1904, the surgeon/practitioner makes a height determination.Rasp trials may be used for further endplate preparation as well as todistract the vertebral space. This allows for the removal of smallirregularities along the endplate better ensuring a smooth surface forcage insertion. Rasp or smooth trials can be used to determine theappropriate size of the cage to be inserted (and, if warranted, thesurgeon/practitioner can modify which cage to utilize so that theappropriate heights of the cage and its anchoring system are proper).Trials also provide the surgeon with tactile feedback as it relates tothe distraction of the vertebral space. The surgeon/practitioner canselect a rasp or smooth trial that corresponds to the preoperativeestimated height and the prepared endplates. The surgeon/practitionercan insert the rasp or smooth trial into the disc space until thedesired height is achieved. The surgeon can confirm height and positionvisually and/or under fluoroscopy.

The surgeon/practitioner should then select a rasp or smooth trial thatcorresponds to the preoperative estimated height of the cage, asapplicable. Trials that can be selected include parallel trials andlordotic trials. The surgeon/practitioner can apply gentle impaction toensure that the trial fits tightly and accurately between the endplates.The surgeon/practitioner can then confirm height, depth, and positionunder fluoroscopy. Care should be taken to protect the nerve roots,dura, and spinal cord while placing rasp trials and/or smooth trials.(This is true also when inserting the implants, including the cage).

In step 1905, the surgeon/practitioner inserts the cage. Optionally, andtypically before such insertion of the cage, the surgeon/practitionercan pack the grafting area of cage with bone graft (such as autologousbone graft) in the interior space of the cage. The surgeon/practitionerselects the cage that corresponds to the rasp trial or smooth trialsize. The cage is inserted with the anchoring mechanism of the cage inthe closed position. The surgeon/practitioner can attach the cage to aninserter tool and use this to insert the cage. (A tamp can be used tocontrol the positing of the cage in the disc space). Thesurgeon/practitioner can insert the cage into the preparedintervertebral space. Gentle impaction on the multi-tool or insertertool will assist in correct positioning.

Once properly positioned, in step 1906, the surgeon/practitioner canthen secure the cage by rotating spindle or lead screw, as the case maybe, so that the anchoring mechanism moves from the closed position tothe opened position. Generally, this is done with a tool other than themulti-tool or inserter tool. However, such tools can be combined. Thisanchors and secures the cage by the opposing forces of the anteriorportion of the superior anchoring section (superior jaw section) and theanterior portions of the inferior anchoring section (inferior jawsection) into the adjacent vertebral endplates. During this step thesurgeon/practitioner can verify the proper placement and anchoring ofthe cage.

If the cage has multiple spindles or lead screws, each of thespindles/lead screws can be moved to cause the anchoring mechanism to bein the opened (anchored) position.

In step 1907, the instrument to move the one or more spindles/leadscrews (as well as the multi-tool or inserting tool) is removed.

In steps 1908, which are optional steps, expansion of the cage andfurther securing can be performed by the surgeon/practitioner. Forinstance, if an expandable cage is utilized (which is not shown in thefigures, but is well known in the art), the cage can be expandedlaterally, vertically, or both, as the case may be. Moreover, thesurgeon/practitioner can further secure the cage by using fasteners(such as screws). Because the cage is already secured and anchored, thecage stays in place during this further securement and anchoring, whichfacilitates the procedure for the surgeon/practitioner.

A medical procedure kit (or set) fully supports the surgical procedureto implant the cage using the medical implant fixation system can besupplied. Such kit can include one or more medical implant fixationdevices (with medical implants, plates, and medical implant fixationinstruments) and some or all of the following tools of a rasp trial, asmooth trial, another trial, inserter, and tamp.

The combination of tools and medical implant fixation systems can bepre-sterilized for ready use.

The disclosures of all patents, patent applications, and publicationscited herein are hereby incorporated herein by reference in theirentirety, to the extent that they provide exemplary, procedural, orother details supplementary to those set forth herein. It will beunderstood that certain of the above-described structures, functions,and operations of the above-described embodiments are not necessary topractice the present invention and are included in the descriptionsimply for completeness of an exemplary embodiment or embodiments. Inaddition, it will be understood that specific structures, functions, andoperations set forth in the above-described referenced patents andpublications can be practiced in conjunction with the present invention,but they are not essential to its practice. It is therefore to beunderstood that the invention may be practiced otherwise than asspecifically described without actually departing from the spirit andscope of the present invention.

While embodiments of the invention have been shown and described,modifications thereof can be made by one skilled in the art withoutdeparting from the spirit and teachings of the invention. Theembodiments described and the examples provided herein are exemplaryonly, and are not intended to be limiting. Many variations andmodifications of the invention disclosed herein are possible and arewithin the scope of the invention. Accordingly, the scope of protectionis not limited by the description set out above.

Concentrations, amounts, and other numerical data may be presentedherein in a range format. It is to be understood that such range formatis used merely for convenience and brevity and should be interpretedflexibly to include not only the numerical values explicitly recited asthe limits of the range, but also to include all the individualnumerical values or sub-ranges encompassed within that range as if eachnumerical value and sub-range is explicitly recited. For example, anumerical range of approximately 1 to approximately 4.5 should beinterpreted to include not only the explicitly recited limits of 1 toapproximately 4.5, but also to include individual numerals such as 2, 3,4, and sub-ranges such as 1 to 3, 2 to 4, etc. The same principleapplies to ranges reciting only one numerical value, such as “less thanapproximately 4.5,” which should be interpreted to include all of theabove-recited values and ranges. Further, such an interpretation shouldapply regardless of the breadth of the range or the characteristic beingdescribed.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood to one of ordinary skill inthe art to which the presently disclosed subject matter belongs.Although any methods, devices, and materials similar or equivalent tothose described herein can be used in the practice or testing of thepresently disclosed subject matter, representative methods, devices, andmaterials are now described.

Following long-standing patent law convention, the terms “a” and “an”mean “one or more” when used in this application, including the claims.

Unless otherwise indicated, all numbers expressing quantities ofingredients, reaction conditions, and so forth used in the specificationand claims are to be understood as being modified in all instances bythe term “about.” Accordingly, unless indicated to the contrary, thenumerical parameters set forth in this specification and attached claimsare approximations that can vary depending upon the desired propertiessought to be obtained by the presently disclosed subject matter.

As used herein, the term “about,” when referring to a value or to anamount of mass, weight, time, volume, concentration or percentage ismeant to encompass variations of in some embodiments ±20%, in someembodiments ±10%, in some embodiments ±5%, in some embodiments ±1%, insome embodiments ±0.5%, and in some embodiments ±0.1% from the specifiedamount, as such variations are appropriate to perform the disclosedmethod.

As used herein, the term “and/or” when used in the context of a listingof entities, refers to the entities being present singly or incombination. Thus, for example, the phrase “A, B, C, and/or D” includesA, B, C, and D individually, but also includes any and all combinationsand subcombinations of A, B, C, and D.

What is claimed is:
 1. A medical implant comprising: (a) a medicalimplant body having a superior surface and an inferior surface, whereinthe superior surface and the inferior surface are on opposing sides ofthe medical implant body, and (b) an anchoring mechanism attached to themedical implant body, wherein the anchoring mechanism comprises (i) asuperior anchoring section having an anterior portion of the superioranchoring section and a posterior portion of the superior anchoringsection, (ii) an inferior anchoring section having an anterior portionof the inferior anchoring section and a posterior portion of theinferior anchoring section, wherein (A) the posterior portion of thesuperior anchoring section is pivotably connected to the posteriorportion of the inferior anchoring section at a pivot joint, and (B) thesuperior anchoring portion and inferior anchoring portion are operableto pivot about the pivot joint such that the anterior portion of thesuperior anchoring portion and the anterior portion of the inferioranchoring portion pivot away from one another, and (iii) at least onespindle or lead screw that is operable to move between a first positionand at least one second position, wherein (A) when the at least onespindle or lead screw is in the first position, the anchoring mechanismis in the closed position with the anterior portion of the superioranchoring section in close proximity to the anterior portion of theinferior anchoring section, (B) when the at least one spindle or leadscrew is in the second position the anchoring mechanism has moved to afirst opened position, (C) in the first opened position, the anteriorportion of the superior anchoring section and the anterior portion ofthe inferior anchoring portion are pivoted away from one another aboutthe pivot joint, and (D) the at last one spindle or lead screw isoperable to be maintained at the second position to lock the anchoringmechanism in the first opened position.
 2. The medical implant of claim1, wherein (a) the at least one spindle or lead screw is at least onespindle.
 3. The medical implant of claim 2, wherein: (a) the medicalimplant body comprises at least one superior recess located at ananterior superior portion of the medical implant body and at least oneinferior recess located at an anterior inferior portion of the medicalimplant body; (b) the anchoring mechanism further comprises a compressoroperatively connected to the superior anchoring section and the inferioranchoring section that provides a compressive force to compress theanchoring mechanism in the closed position; (c) each of the at least onespindle has a separator, wherein (i) the spindle is located between theanterior portion of the superior anchoring section and the anteriorportion of the inferior anchoring section and at the anterior portion ofthe medical implant, (ii) the spindle is rotatable so that the separatoris operable to move between a first spindle position and a secondspindle position, (iii) when the separator is in the first spindleposition, the anchoring mechanism is in the closed position, (iv) whenthe separator is in the second spindle position, the anchoring mechanismis in the first opened position, and (v) when the separator is in thesecond position, the separator is in contact with at least one of the atleast one superior recess and at least one of the at least one inferiorrecess, which are operable to maintain the separator in the secondseparator position which maintains the spindle in the second position.4. The medical implant of claim 3, wherein the anchoring mechanism is asingle-opened-height controlled anchoring system.
 5. The medical implantof claim 3, wherein the anchoring mechanism is a multiple-opened-heightcontrolled anchoring system.
 6. The medical implant of claim 5, wherein:(a) the medical implant body comprises at least one additional superiorrecess located at the anterior superior portion of the medical implantbody and at least one additional inferior recess located at the anteriorinferior portion of the medical implant body, (b) the medical implantcomprises a locking ring operable to lock the spindle, wherein (i) thespindle is rotatable so that the separator is operable to move betweenthe first spindle position and a third spindle position, (ii) when theseparator is in the third spindle position, the anchoring mechanism isin a second opened position that is different than the first openedposition, (iv) when the separator is in the third spindle position, theseparator is in contact with at least one of the at least one additionalsuperior recess and at least one of the at least one additional inferiorrecess, and (v) the locking ring is operable to lock the spindle fromrotating.
 7. The medical implant of claim 3, wherein the anchoringmechanism comprises at least two spindles.
 8. The medical implant ofclaim 1, wherein the at least one spindle or lead screw is at least onelead screw, and the anchoring mechanism is a variable-opened-heightcontrolled anchoring system
 9. The medical implant of claim 8, wherein(a) the at least one lead screw is operable to move to at least a thirdposition, and (b) when the at least one lead screw is in the thirdposition, the anchoring mechanism has moved to a second opened positionin which the anterior portion of the superior anchoring section and theanterior portion of the inferior anchoring portion are pivoted away fromone another about the pivot joint even farther than when the lead screwwas in the second position.
 10. The medical implant of claim 9, whereinwhen the at least one lead screw is in the third position, the anchoringmechanism is in a fully opened position.
 11. The medical implant ofclaim 10, wherein (a) the at least one lead screw is operable to move toat least a fourth position, (b) when the at least one lead screw is inthe fourth position, the anchoring mechanism has moved to a third openedposition, and (c) in the third opened position, the anchoring mechanismis more opened than when in the first opened position and less openedwhen in the second opened position.
 12. The medical implant of claim 1,wherein the medical implant is a cage.
 13. The medical implant of claim12, wherein the cage is a lumbar cage.
 14. The medical implant of claim13, wherein the lumbar cage comprises at least two of the spindles or atleast two of the lead screws.
 15. The medical implant of claim 13,wherein the lumbar cage is a thoraco-lumbar cage.
 16. The medicalimplant of claim 13, wherein the lumbar cage has a length and a widthselected from a group consisting of 22 mm×30 mm, 24 mm×32 mm, 28 mm×36mm, and 32 mm×40 mm.
 17. The medical implant of claim 12, wherein is thecage is a cervical cage.
 18. The medical implant of claim 17, whereinthe cervical cage comprises exactly one spindle or exactly one leadscrew.
 19. The medical implant of claim 17, wherein the cervical cagehas a length and a width selected from a group consisting of 12 mm×14mm, 14 mm×17 mm, and 16 mm×20 mm.
 20. The medical implant of claim 1,wherein the medical implant has a height between 5 mm and 22 mm.
 21. Themedical implant of claim 1, wherein the medical implant is a vertebralbody replacement having a height between 20 mm and 100 mm.
 22. Themedical implant of claim 1, wherein the medical implant comprises amaterial selected from a group consisting of biocompatible radiolucentpolymers, non-radiolucent metal alloys, carbon fibers, composites ofcarbon fibers and polymers, and combinations thereof.
 23. The medicalimplant of claim 1, wherein the anchoring mechanism comprises a materialselected from a group consisting of metal alloys, ceramics, polymers,and composites thereof.
 24. The medical implant of claim 1, wherein theanchoring mechanism comprises a metal alloy or a carbon composite. 25.The medical implant of claim 24, wherein the metal alloy comprises atitanium metal alloy.
 26. The medical implant of claim 1, wherein themedical implant body is a non-expandable medical implant body.
 27. Themedical implant of claim 1, wherein the medical implant body is anexpandable medical implant body.
 28. The medical implant of claim 27,wherein the anchoring mechanism is operable to anchor the medicalimplant before expanding the expandable medical implant body.
 29. Themedical implant of claim 27, wherein the expandable medical implant bodyexpands in a vertical direction to expand the height of the medicalimplant body, wherein the maximum expanded height of the expandablemedical implant body is less than the difference between the anteriorportion of the superior anchoring section and the anterior portion ofthe inferior anchoring section when the anchoring mechanism is in thefirst opened position.
 30. The medical implant of claim 1 furthercomprising a plurality of fastener window features through which afastener can pass through for anchoring of the medical implant.
 31. Themedical implant of claim 30, wherein the plurality of fastener windowfeatures are operable for receiving a fastener selected from a groupconsisting of (a) fixed angle screws, (b) variable angle screws, (c)self-drilling screws, (d) self-tapping screws, and (e) combinationsthereof.